Medical device recalls
38685 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2023-06-28FDA-DeviceMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)Class IICD COBALT XT DR MRI IS1 DF1, Model Number DDPA2D1; Implantable Cardioverter Defibrillators
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific (glassed) feedthrough, including currently available ICDs and CRT-Ds.
- 2023-06-28FDA-DeviceMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)Class IICD-DR DDME3D4 MIRRO MRI, Model Number DDME3D4; Implantable Cardioverter Defibrillators
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific (glassed) feedthrough, including currently available ICDs and CRT-Ds.
- 2023-06-28FDA-DeviceMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)Class IICD-DR DDME3D1 MIRRO MRI, Model Number DDME3D1; Implantable Cardioverter Defibrillators
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific (glassed) feedthrough, including currently available ICDs and CRT-Ds.
- 2023-06-28FDA-DeviceMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)Class IICD-DR DDMD3D4 PRIMO MRI, Model Number DDMD3D4; Implantable Cardioverter Defibrillators
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific (glassed) feedthrough, including currently available ICDs and CRT-Ds.
- 2023-06-28FDA-DeviceMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)Class IICD-DR DDMD3D1 PRIMO MRI, Model Number DDMD3D1; Implantable Cardioverter Defibrillators
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific (glassed) feedthrough, including currently available ICDs and CRT-Ds.
- 2023-06-28FDA-DeviceMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)Class IICD-DR DDMC3D4 EVERA MRI S IS-1/DF4 GLOB, Model Number DDMC3D4; Implantable Cardioverter Defibrillators
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific (glassed) feedthrough, including currently available ICDs and CRT-Ds.
- 2023-06-28FDA-DeviceMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)Class IICD-DR DDMC3D1 EVERA MRI S OUS/US DF1, Model Number DDMC3D1; Implantable Cardioverter Defibrillators
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific (glassed) feedthrough, including currently available ICDs and CRT-Ds.
- 2023-06-28FDA-DeviceMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)Class IICD-DR DDMB2D4 EVERA MRI XT IS-1/DF4 INT, Model Number DDMB2D4; Implantable Cardioverter Defibrillators
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific (glassed) feedthrough, including currently available ICDs and CRT-Ds.
- 2023-06-28FDA-DeviceMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)Class IICD-DR DDMB2D1 EVERA MRI XT OUS DF1, Model Number DDMB2D1; Implantable Cardioverter Defibrillators
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific (glassed) feedthrough, including currently available ICDs and CRT-Ds.
- 2023-06-28FDA-DeviceMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)Class IICD-DR DDMB1D4 EVERA MRI XT IS-1/DF4 US, Model Number DDMB1D4; Implantable Cardioverter Defibrillators
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific (glassed) feedthrough, including currently available ICDs and CRT-Ds.
- 2023-06-28FDA-DeviceMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)Class IICD-DR DDMB1D1 EVERA MRI XT US DF1, Model Number DDMB1D1; Implantable Cardioverter Defibrillators
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific (glassed) feedthrough, including currently available ICDs and CRT-Ds.
- 2023-06-28FDA-DeviceMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)Class IICD-DR DDBC3D4 EVERA S IS1/DF4 GLOB, Model Number DDBC3D4; Implantable Cardioverter Defibrillators
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific (glassed) feedthrough, including currently available ICDs and CRT-Ds.
- 2023-06-28FDA-DeviceMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)Class IICD-DR DDBC3D1 EVERA S IS1/DF1 GLOB, Model Number DDBC3D1; Implantable Cardioverter Defibrillators
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific (glassed) feedthrough, including currently available ICDs and CRT-Ds.
- 2023-06-28FDA-DeviceMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)Class IICD-DR DDBB2D4 EVERA XT IS1/DF4 INTL, Model Number DDBB2D4; Implantable Cardioverter Defibrillators
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific (glassed) feedthrough, including currently available ICDs and CRT-Ds.
- 2023-06-28FDA-DeviceMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)Class IICD-DR DDBB2D1 EVERA XT IS1/DF1 INTL, Model Number DDBB2D1; Implantable Cardioverter Defibrillators
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific (glassed) feedthrough, including currently available ICDs and CRT-Ds.
- 2023-06-28FDA-DeviceMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)Class IICD EVERA XT DR GOLD CTD, Model Number DDBB1D4G; Implantable Cardioverter Defibrillators
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific (glassed) feedthrough, including currently available ICDs and CRT-Ds.
- 2023-06-28FDA-DeviceMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)Class IICD-DR DDBB1D4 EVERA XT IS1/DF4 US, Model Number DDBB1D4; Implantable Cardioverter Defibrillators
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific (glassed) feedthrough, including currently available ICDs and CRT-Ds.
- 2023-06-28FDA-DeviceMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)Class IICD-DR DDBB1D1 EVERA XT IS1/DF1 US, Model Number DDBB1D1; Implantable Cardioverter Defibrillators
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific (glassed) feedthrough, including currently available ICDs and CRT-Ds.
- 2023-06-21FDA-DeviceAmerican Contract Systems, Inc.Class IIITotal Knee Pack, REF CETJ130, medical convenience kits
Incorrect expiration date on product.
- 2023-06-21FDA-DeviceBoston Scientific Neuromodulation CorporationClass IIDriver Instrument, part of the Superion Indirect Decompression System, REF: 102-9800, used with the Superion Indirect Decompression System IFU, Superion IDS Kit IFU, Surgical Technique Manual
Pending update to indirect decompression system instructions for use informing users that excessive force during the implant procedure may cause driver instrument tip breaks, which may result in metal fragments (Driver teeth/tips) within the implant location; and if metal fragments are not removed and remain in situ, MRI scans are NOT advised due to potential risk of patient injury.
- 2023-06-21FDA-DeviceLumiraDxClass IISteriPack Sterile Polyester Spun Swabs (25 units/Pack)- Intended for sample collection in the intended nasal area. Catalog Number: 60566RevB
Fails Post-Sterilization Sterile Swabs Cantilever (Bend) Testing and may be more susceptible to breakage. If the swab breaks in the nasal cavity of a patient may cause injury or medical intervention to remove part of the swab
- 2023-06-21FDA-DeviceGalt Medical CorporationClass IITearaway Introducer Set, REF: INT-028-27, INT-105-25, INT-106-09, INT-106-12, INT-106-17, DSS-007-04, DSS-007-05, DSS-010-065, DSS-012-07 (bulk)
Sheath introducer assemblies could potentially, due to improper storage conditions, have a luer connection portion of the dilator hub that cracks or dislodges during use, which renders the dilator component unusable, and can require the use of a replacement device.
- 2023-06-21FDA-DeviceGalt Medical CorporationClass IITearaway Introducer Kit, REF: KIT-010-12, KIT-010-17, KIT-900-16
Sheath introducer assemblies could potentially, due to improper storage conditions, have a luer connection portion of the dilator hub that cracks or dislodges during use, which renders the dilator component unusable, and can require the use of a replacement device.
- 2023-06-21FDA-DeviceVyaire MedicalClass IIbellavista 1000e Ventilator, Catalogue Number 301.100.130; Continuous Use Ventilator
Vyaire Medical identified two patient safety risks during the use of the bellavista 1000 and bellavista 1000e: 1. Under certain conditions of use, the touchscreen may become unresponsive and the device application stops responding (APP Hang). When this occurs, if the user continues to interact with the touchscreen, a message will appear that states DeviceSoftware.Application is not responding or a decommission screen will appear on the user interface. The ventilator will issue both an audible and visual alarm. Ventilation continues without interruption with the settings applied prior to the APP Hang error. 2. The potential for a use error has been identified if the operator applies the proposed settings without confirming the settings are suitable for the patient.
- 2023-06-21FDA-DeviceVyaire MedicalClass IIbellavista 1000 Ventilator, Catalogue Number 301.100.030; Continuous Use Ventilator
Vyaire Medical identified two patient safety risks during the use of the bellavista 1000 and bellavista 1000e: 1. Under certain conditions of use, the touchscreen may become unresponsive and the device application stops responding (APP Hang). When this occurs, if the user continues to interact with the touchscreen, a message will appear that states DeviceSoftware.Application is not responding or a decommission screen will appear on the user interface. The ventilator will issue both an audible and visual alarm. Ventilation continues without interruption with the settings applied prior to the APP Hang error. 2. The potential for a use error has been identified if the operator applies the proposed settings without confirming the settings are suitable for the patient.
- 2023-06-21FDA-DeviceHowmedica Osteonics Corp.Class IIExeter V40 Trial Head, 26mm, -3, Catalog Number 6364-8-026
The Exeter V40 Trial Head, catalog number 6364-8-026 (size 26mm, -3) may appear green, when it is meant to be a blue color. Green signifies a size 26mm, +3 Trial Head.
- 2023-06-21FDA-DeviceMerit Medical Systems, Inc.Class IIAspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-15-5, STERILE EO, Rx Only *EU Distribution only
There is a potential that valve assemblies will not open. preventing fluid from draining.
- 2023-06-21FDA-DeviceMerit Medical Systems, Inc.Class IIAspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-15, STERILE EO, Rx Only *EU Distribution only
There is a potential that valve assemblies will not open. preventing fluid from draining.
- 2023-06-21FDA-DeviceMerit Medical Systems, Inc.Class IIAspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-11-5, STERILE EO, Rx Only *EU Distribution only
There is a potential that valve assemblies will not open. preventing fluid from draining.
- 2023-06-21FDA-DeviceMerit Medical Systems, Inc.Class IIAspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-11, STERILE EO, Rx Only *EU Distribution only
There is a potential that valve assemblies will not open. preventing fluid from draining.
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